Skin Cancer, Non-MelanomaNCT03457766
Presurgical Evaluation of Skin Cancers Using HIFU
A study testing HIFU in people with Skin Cancer, Non-Melanoma, run by Assiut University at 1 site in Egypt.
Trial summary
1. To ensure complete elimination of lesions with maximum preservation of function and aesthetics. 2. To elaborate the Ultrasonographic features of skin cancers. 3. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination.. 4. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Skin Cancer, Non-Melanoma
- What is being tested?
- HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 13 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 30 \& 80 years.
- Lesions clinically apparent locally malignant, or malignant.
- Lesions with or without visible ulcerations.
Who cannot join
- Surgeon unable to visualize tumor on clinical examination.
- Patients unfit for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound
- To ensure complete elimination of lesions with maximum preservation of function and aesthetics.
- To elaborate the Ultrasonographic features of skin cancers.
- To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..
- To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.
Read the detailed description
The skin is the most superficial and largest body organ, due to its function as a surface covering for the body, enables the performance of noninvasive diagnostic and investigative procedures.
Of all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
Techniques such as high frequency ultrasound (HFUS) enable the real-time study of cutaneous lesions, making them excellent pre-operative tools varying considerably in their penetration, resolution, and applicability.
High frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a painless non-radioactive imaging diagnostic method based on the reflection of sound waves through body tissues.
High frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic perilesional area.
High frequency ultrasound examination of each lesion should consist of:
- A morphologic study analyzing the structural sonographic pattern and margins;
- the measurement of the largest transverse diameter and thickness;
- Color Doppler USG for perilesional vessels ; and
- in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.
- Conditions
- Skin Cancer, Non-Melanoma
- Being tested
- HIFU
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUDevice
Also called Esaota MyLabSeven
Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency
| Study group | Role | What they receive |
|---|---|---|
| Patients with skin lesions | Experimental | Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant Receives: Device: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete excision of nonmelanoma skin cancers
Determination the accuracy of HIFU to assess the margins of skin lesions and its safety margins to ensure complete elimination of lesions with maximum preservation of function and aesthetics
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Apr 2018
- Primary completion15 May 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Skin Cancer, Non-MelanomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using high frequency ultrasound in identification of safety margins of skin cancers
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Gamil Gergis, Assiut University
- Investigators
- Mostafa AH El-Sonbaty, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457766
- Sponsor's protocol ID
- HIFU in skin cancers
- Status last verified
- Nov 2022
- First submitted
- 24 Feb 2018
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.
PubMed 19043850Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014 Mar 1;383(9919):816-27. doi: 10.1016/S0140-6736(13)60802-8. Epub 2013 Sep 19.
PubMed 24054424Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. 2010 Feb 20;375(9715):673-85. doi: 10.1016/S0140-6736(09)61196-X.
PubMed 20171403Kleinerman R, Whang TB, Bard RL, Marmur ES. Ultrasound in dermatology: principles and applications. J Am Acad Dermatol. 2012 Sep;67(3):478-87. doi: 10.1016/j.jaad.2011.12.016. Epub 2012 Jan 30.
PubMed 22285673Bobadilla F, Wortsman X, Munoz C, Segovia L, Espinoza M, Jemec GB. Pre-surgical high resolution ultrasound of facial basal cell carcinoma: correlation with histology. Cancer Imaging. 2008 Sep 22;8(1):163-72. doi: 10.1102/1470-7330.2008.0026.
PubMed 18812268Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002 Apr;146 Suppl 61:1-6. doi: 10.1046/j.1365-2133.146.s61.2.x.
PubMed 11966724Essers BA, Dirksen CD, Nieman FH, Smeets NW, Krekels GA, Prins MH, Neumann HA. Cost-effectiveness of Mohs Micrographic Surgery vs Surgical Excision for Basal Cell Carcinoma of the Face. Arch Dermatol. 2006 Feb;142(2):187-94. doi: 10.1001/archderm.142.2.187.
PubMed 16490846Ansarin H, Daliri M, Soltani-Arabshahi R. Expression of p53 in aggressive and non-aggressive histologic variants of basal cell carcinoma. Eur J Dermatol. 2006 Sep-Oct;16(5):543-7.
PubMed 17101476
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound
- ClinicalTrials.gov ID
- NCT03457766
- Acronym / sponsor ID
- HIFU in skin cancers
- Conditions
- Skin Cancer, Non-Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To ensure complete elimination of lesions with maximum preservation of function and aesthetics.
- To elaborate the Ultrasonographic features of skin cancers.
- To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..
- To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.
Detailed description
The skin is the most superficial and largest body organ, due to its function as a surface covering for the body, enables the performance of noninvasive diagnostic and investigative procedures.
Of all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
Techniques such as high frequency ultrasound (HFUS) enable the real-time study of cutaneous lesions, making them excellent pre-operative tools varying considerably in their penetration, resolution, and applicability.
High frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a painless non-radioactive imaging diagnostic method based on the reflection of sound waves through body tissues.
High frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic perilesional area.
High frequency ultrasound examination of each lesion should consist of:
- A morphologic study analyzing the structural sonographic pattern and margins;
- the measurement of the largest transverse diameter and thickness;
- Color Doppler USG for perilesional vessels ; and
- in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using high frequency ultrasound in identification of safety margins of skin cancers
| Arm | Type | Receives |
|---|---|---|
| Patients with skin lesions | Experimental | Device: HIFUUsing HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 30 \& 80 years.
- Lesions clinically apparent locally malignant, or malignant.
- Lesions with or without visible ulcerations.
Key exclusion criteria (2 listed)
- Surgeon unable to visualize tumor on clinical examination.
- Patients unfit for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFUAlso: Esaota MyLabSevenUltrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency | Device | Patients with skin lesions |
Primary outcome
Complete excision of nonmelanoma skin cancers
Time frame: Baseline
Determination the accuracy of HIFU to assess the margins of skin lesions and its safety margins to ensure complete elimination of lesions with maximum preservation of function and aesthetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Background: PubMed 19043850Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.
- Background: PubMed 24054424Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014 Mar 1;383(9919):816-27. doi: 10.1016/S0140-6736(13)60802-8. Epub 2013 Sep 19.
- Background: PubMed 20171403Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. 2010 Feb 20;375(9715):673-85. doi: 10.1016/S0140-6736(09)61196-X.
- Background: PubMed 22285673Kleinerman R, Whang TB, Bard RL, Marmur ES. Ultrasound in dermatology: principles and applications. J Am Acad Dermatol. 2012 Sep;67(3):478-87. doi: 10.1016/j.jaad.2011.12.016. Epub 2012 Jan 30.
- Background: PubMed 18812268Bobadilla F, Wortsman X, Munoz C, Segovia L, Espinoza M, Jemec GB. Pre-surgical high resolution ultrasound of facial basal cell carcinoma: correlation with histology. Cancer Imaging. 2008 Sep 22;8(1):163-72. doi: 10.1102/1470-7330.2008.0026.
- Background: PubMed 11966724Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002 Apr;146 Suppl 61:1-6. doi: 10.1046/j.1365-2133.146.s61.2.x.
- Background: PubMed 16490846Essers BA, Dirksen CD, Nieman FH, Smeets NW, Krekels GA, Prins MH, Neumann HA. Cost-effectiveness of Mohs Micrographic Surgery vs Surgical Excision for Basal Cell Carcinoma of the Face. Arch Dermatol. 2006 Feb;142(2):187-94. doi: 10.1001/archderm.142.2.187.
- Background: PubMed 17101476Ansarin H, Daliri M, Soltani-Arabshahi R. Expression of p53 in aggressive and non-aggressive histologic variants of basal cell carcinoma. Eur J Dermatol. 2006 Sep-Oct;16(5):543-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa AH El-Sonbaty, Professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU in people with Skin Cancer, Non-Melanoma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete excision of nonmelanoma skin cancers (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457766, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.